- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02958254
Ultrasound Measurements Hamstring Muscles Thickness
Ultrasound Measurements of Hamstring Muscles Thickness Are a Valid Tool
No previous studies have compared the association between muscle thickness (MT) and muscle cross-sectional area (CSA) in healthy volunteers. The main aim of this study is to investigate the validity of ultrasound in assessing the muscle thickness of hamstrings muscle.
Study design:
A cross-sectional-validity study.
Setting:
University
Participants:
X football players of an amateur football team (X healthy volunteers and X patients with a previous hamstring injury).
Study Overview
Status
Conditions
Detailed Description
X healthy volunteers, from an amateur football team, and X football players with previous history of hamstring injury from an orthopaedic clinic, comprised the subjects in this study. Hamstring muscle injury was defined as "a traumatic distraction or overuse injury to the hamstring muscle leading to a player being unable to fully participate in training or match play".
The Control Group (CG) were healthy, had neither surgery/trauma in their lower extremities, nor history of hamstring injury, and there were no abnormal findings in their physical examination. The exclusion criteria included participants who: (1) had metal implants or pace makers, (2) weighted more than 200 kg (MRI table limitations), and (3) were unable to complete testing. In the Injured Group, patients were also excluded if their previous injury was originated from a non-muscular source (e.g., inguinal or femoral hernia, nerve entrapment, lumbosacral pathology), or if still had symptoms, had not returned to practice and had not been participating in track and field since their last injury.
The Study Group (SG) had history and diagnosis of hamstring injury assessment with diagnosis image technique (ultrasound or MRI), and at least 2 of the next criteria: 1. When the injury happened disability to practise with the team at least one week; 2. Lost at least one match; 3. Felt pain when trying to kick the ball or run fast; 4. Receive specific treatment (medical or physiotherapy) for the injury; 5. Needed a period plan to return to play.
Participants were screened for contraindications to MRI before ultrasound assessment and an MRI scan of the hamstring muscles of both legs were performed. MRI was performed within 24 h of the ultrasound scan. The subjects were instructed not to consume alcohol or perform any moderate to heavy exercise for 24 hours prior to each imaging session.
Muscle thickness was defined as the distance between the bone-muscle interface and the adipose tissue-muscle interface. The measurement was made from the most superficial edge of the bright line representing the interface of the bony cortex and the muscle to the most superficial edge of the bright line representing the interface of the outer fascial layer of the muscle and the subcutaneous adipose tissue. When the bone was not in contact of the muscle the two fascial layer were used.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Practice at least twice per week
- Playing soccer more than 5 years
- Inform Consent signed
Exclusion Criteria:
- 18 years or older
- Had metal implants or pace makers
- Weighted more than 200 kg (MRI table limitations)
- Were unable to complete testing
Injuries players:
- History and diagnosis of hamstring injury
- Assessment with diagnosis image technique (ultrasound or MRI)
At least 2 of the next criteria:
- When the injury happened disability to practise with the team at least one week;
- Lost at least one match
- Felt pain when trying to kick the ball or run fast
- Receive specific treatment (medical or physiotherapy) for the injury
- Needed a period plan to return to play
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hamstring muscles thickness in millimeters by Ultrasound
Time Frame: 30 minutes
|
30 minutes
|
Hamstring muscles thickness in millimeters by Magnetic Resonance Image
Time Frame: 1 hour
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cross-Sectional Area of the hamstring muscles in square millimeters by Ultrasound
Time Frame: 30 minutes
|
30 minutes
|
Cross-Sectional Area of the hamstring muscles in square millimeters by Magnetic Resonance Image
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Josep Benítez-Martínez, University of Valencia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H1458067703008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Muscle Atrophy
-
Robert WestermannWithdrawnMuscle Atrophy | ACL Tear | Quadriceps Muscle Atrophy | Muscle Atrophy, ProximalUnited States
-
Athanasios EllinoudisCompletedMuscle Atrophy or Weakness | Muscle Contraction | Core StabilityGreece
-
University of JazanCompletedQuadriceps Muscle AtrophySaudi Arabia
-
DLR German Aerospace CenterCompletedMuscle; Atrophy, GeneralGermany
-
Cincinnati Sportsmedicine Research and Education...CompletedMuscle Weakness | Severe Muscle AtrophyUnited States
-
Amsterdam UMC, location VUmcCompletedCritical Illness | Muscle Atrophy or Weakness | Mechanical Ventilation | Diaphragm | Expiratory MuscleNetherlands
-
Christian Müller, MDUniversity Hospital Inselspital, Berne; Medical University Innsbruck; University... and other collaboratorsRecruitingMuscle Weakness | Muscle Atrophy | Muscle Spasticity | Muscle Cramp | Muscle Soreness | Muscle Damage | Myopathy | Muscle InjurySwitzerland, Austria
-
University of NottinghamUnknownSarcopenia | Muscle Atrophy | Muscle HypotrophyUnited Kingdom
-
Istanbul UniversityRecruitingEMG | Quadriceps Muscle Atrophy | TourniquetTurkey